Annuloplasty ring delivery method

ABSTRACT

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

RELATED APPLICATIONS

[0001] This application is a continuation-in-part of co-pending U.S.patent application Ser. No. 387,909, filed on Jul. 31, 1989 and Ser. No.444,189 filed on Nov. 30, 1989. The present invention relates to asurgical suture guide used to control the dimension and/or shape of asuture line placed during surgical repair of an organ or body part. Inparticular, the present invention relates to a combination of a flexiblesuture guide releasably attached to a rigid holder for controlling thespacing and placement of surgical sutures.

BACKGROUND OF THE INVENTION

[0002] During surgical repair of an organ or other body part, thesurgeon typically makes an incision to open the organ. Upon closure ofthe surgical wound, sutures are placed in the various layers of tissueto draw the two edges of the wound together so that the healing processcan reform a smooth and competent surface. However, sutures often tearthrough the tissue if they are subjected to stress, thus damaging thesurgical closure of the wound. It would be desirable in many instancesto have a means for lending permanent support to strengthen and supportthe wall of the organ into which the surgical incision has been placed.Alternatively, in many instances it would be preferred to have abiodegradable suture guide.

[0003] In many cases, the incision is not a straight line, but is shapedto conform to an anatomical requirement, making it difficult for thesurgeon to balance the tension on the sutures to form the desired shape.In a number of instances the suture line is substantially curvilinearand it is of utmost importance that the suture line maintain apredetermined dimension. For example, when two blood vessels, or othervessels, such as intestines, are sutured together, the need exists forsome means of preventing the suture line from constricting the vessel soas to create a potential point of blockage. Similar problems ariseduring bowel and bronchial resection. As another example, when thesurgeon is reducing the size of a stomach by surgical means, the needexists for a means to assure that the reshaped organ will have aparticular circumferential dimension and that the pleats used to reducethe size of the organ are evenly distributed so as to avoid formation ofareas of reduced flexibility along the suture line. In other situations,such as in cosmetic surgery, the surgeon may desire to assure that thesuture line is limited to a predetermined length.

[0004] In all of these situations, it is desirable to use a suture guideto aid the surgeon in achieving the desired dimension of the surgicalclosure and/or to rigidly support the area where the sutures are placed,thus avoiding the danger that the sutures will tear through the tissueor that the suture line will act like a draw string and undesirablybunch up the tissue.

[0005] These problems are particularly acute in the surgical procedureknown as annuloplasty wherein any of a number of types of prostheseshave been used in surgical correction of deformed mitral or bicuspidheart valves.

[0006] Diseases and certain natural defects to heart valves can impairthe functioning of the cusps of the valves in preventing regurgitationof blood from the ventricle into the atrium when the ventriclecontracts. For example, rheumatic fever and bacterial inflammations ofthe heart tissue can distort or dilate the valvular annulus, thusresulting in displacement of the cusps away from the center of the valveand causing leakage of blood during ventricle contraction.

[0007] Two techniques, generally known as annuloplasty, are- used toreshape the distended and/or deformed valve annulus. In the techniqueknown as “plication,” the circumference of the valve annulus is reducedby implanting a rigid or semi-rigid prosthetic ring of reducedcircumference about the base of the annulus while the annulus is pleatedto reduce its circumference to that of the ring. In the technique knownas “reconstruction”, the circumference of the annulus is not reduced,but the annulus is restructured into an elongate shape. To accomplishthis goal, a rigid or semi-rigid ring having the same circumference asthe annulus but in an elongate or elliptical shape is surgicallyimplanted about the base of the valve. Both plication and restructuringare intended to eliminate the gap in the closure of the distended valveby bringing back together the tips of the valve cusps.

[0008] Many different types of prostheses have been developed for use inannuloplasty surgery. In general, prostheses are annular or partiallyannular shaped members that fit about the base of the valve annulus.Initially the prostheses were designed as rigid frame members, or“rings”, of metallic or other rigid materials that flex little, if atall, during the normal opening and closing of the valve. Since a normalheart valve annulus continuously flexes during the cardiac cycle, arigid ring prosthesis interferes with this movement and therebyrestricts movement of the valve itself. Sutures used to implant rigidring prostheses consequently undergo stresses sufficient to tear thesutures loose. Examples of rigid annuloplasty ring prostheses aredisclosed in U.S. Pat. No. 3,656,185, issued to Carpentier on Apr. 18,1972; and U.S. Pat. No. 4,164,046, issued to Cooley on Aug. 14, 1979.

[0009] Others have suggested the use of completely flexible annuloplastyring prostheses. Examples of completely flexible ring prostheses aredisclosed in U.S. Pat. No. 4,290,151, issued to Massana on Sep. 22,1981, and are discussed in the articles of Carlos D. Duran and Jose LuisM. Ubago, “Clinical and Hemodymanic Performance of a Totally FlexibleProsthetic Ring for Atrioventricular Valve Reconstruction”, 5 Annals ofThoracic Surgery, (No. 5), 458-463, (November 1976) and M. Puig Massanaet al, “Conservative Surgery of the Mitral Valve Annuloplasty on a NewAdjustable Ring”, Cardiovascular Surgery 1980, 30-37, (1981).

[0010] Flexible prostheses generally include an inner support memberformed from a flexible material. This support member is wrapped inwoven, biocompatible cloth material. Realignment of the valve cuspsduring opening and closing of the valve is obtained by the propersuturing of the ring about the valve annulus. However, completelyflexible ring prostheses provide almost no support to the suture areaduring the precarious implant procedure. Even though the surgeonattempts to evenly distribute the sutures along the periphery of thevalvular annulus, during implant the drawstring effect of the suturestends to bunch the material covering the flexible ring so that thesutures also bunch together at localized areas around the ring. Thisphenomenon, known as multiple plications in the heart valve annulus,causes rigid areas around the annulus. Thus, the flexible ring actuallyends by imparting areas of rigidity and thereby distorts the valveannulus during the opening and closing of the valve despite the desiredreduction in circumference of the valvular annulus.

[0011] To overcome some of the drawbacks of rigid ring prostheses, stillfurther types of annuloplasty prostheses have been designed to allow foradjustment of the ring circumference, either by the surgeon duringimplant, or automatically as the implanted. ring moves during theopening and closing of the valve. This type of adjustable prosthesis istypically designed in combination with a rigid, or at least partiallyrigid, frame.

[0012] An example of a self adjusting ring prosthesis is taught in U.S.Pat. No. 4,489,446, issued to Reed on Dec. 25, 1984. To provide for selfadjustment of the prosthetic annul-us, two reciprocating rigid metalpieces form the frame. U.S. Pat. No. 4,602,911, issued to Ahmadi et al.and U.S. Pat. No. 4,042,979, issued to Angell on Aug. 23, 1977, providefurther adjustable ring protheses having a mechanism for adjusting thecircumference of the ring. But due to rigidity of the frame members, theself-adjusting prostheses do not overcome many of the disadvantages ofother types of rigid ring prostheses.

[0013] U.S. Pat. No. 4,055,861, issued to Carpentier on Nov. 1, 1977,teaches an annuloplasty ring prosthesis having a flexibility between thecompletely flexible rings discussed above and the various types of rigidring. The ring of Carpentier is deformable to an equal degree andsimultaneously in all directions and preferably has the elasticity of anannular bundle of 2 to 8 turns of a cylindrical bristle of poly(ethyleneterephthalate).

[0014] While rigid and semi-rigid annuloplasty rings eliminate thebunching caused by flexible rings, the restrictive nature of such ringsis generally detrimental to the valve's ability to open and closenormally. It thus remains an object of the invention to provide asurgical means for reshaping a deformed or dilated heart valve annulushaving none of the above described drawbacks associated with knownannuloplasty ring prostheses.

[0015] For use in annuloplasty of heart valves, as in otherapplications, it is desirable that a suture guide be entirely flexible,light weight, and compliant while having sufficient strength towithstand stress placed upon the sutures sewn through and around it.However, an entirely flexible suture guide cannot prevent bunching ofthe tissue in the draw-string effect described above and thus cannotassure that the suture line and the tissue into which it is placed willmaintain any desired dimension, for example, a desired circumference.Therefore the need exists for a means of temporarily providing rigidityand fixed dimension to the suture guide during the surgery, butrendering the suture-guide freely flexible once the surgery has beenaccomplished.

DESCRIPTION OF THE DRAWINGS

[0016] The present invention may be better understood and the advantageswill become apparent to those skilled in the art by reference to theaccompanying drawings, wherein like reference numerals refer to likeelements in the several figures, and wherein:

[0017]FIG. 1 is a perspective exploded view of a flexible suture guidemounted on a rigid holder assembly in accordance with an embodiment ofthe invention

[0018]FIG. 1A is a top view in partial cross-section of a length of aflexible suture guide in accordance with the present invention.

[0019]FIG. 1B is a top view in partial cross-section of the flexiblesuture guide of the present invention sutured into a ring configuration.

[0020]FIG. 2 is an exploded view of the guide mount portion and lowerpart of the handle portion of the holder assembly of FIG. 1 without thesuture guide.

[0021]FIG. 3 is a perspective view of a flexible suture guide of thepresent invention mounted on the assembled guide mount and lower handleportions seen in FIG. 2.

[0022]FIG. 4 is a cross-sectional view of the assembled guide mount andlower handle portions of FIG. 3 along line 4-4.

[0023]FIG. 5 is a top view of the guide mount seen in FIG. 3 with aflexible suture guide tautly secured thereto.

[0024]FIG. 6 is a perspective view of a guide mount in accordance withanother embodiment of the invention.

[0025]FIG. 7 is a cross-sectional view of a suture guide having alenticular cross-sectional shape in accordance with another embodimentof the invention.

[0026]FIG. 8 is a side perspective sectional view of a handle assemblyin accordance with another embodiment of the invention.

[0027]FIG. 9 is a bottom view of the handle extension of FIG. 8.

[0028]FIG. 10 is a top view of the housing of FIG. 8.

[0029]FIG. 11 is a perspective view of a suture guide holder inaccordance with another embodiment of the invention.

[0030]FIG. 12 is an exploded view of the guide mount portion and lowerhandle portion of the suture guide holder of FIG. 11.

[0031]FIG. 13 is a top view of the guide mount portion of the sutureguide holder of FIG. 11.

[0032]FIG. 14 is a perspective view of a linear suture guide holder inaccordance with another embodiment of the invention.

[0033]FIG. 15 is a perspective view of the suture guide holder of FIG.14 with a suture guide attached.

[0034]FIG. 16 is a perspective view of a circular suture guide holder inaccordance with another embodiment of the invention.

[0035]FIG. 17 is a perspective view of the suture guide holder of FIG.16 with a suture guide attached.

[0036]FIG. 18 is a cross-sectional view of the suture guide and holderof FIG. 17 taken along line 18-18.

SUMMARY OF THE INVENTION

[0037] The present invention overcomes the above discussed disadvantagesby providing an assembly for holding a substantially flexible sutureguide in a substantially taut position for placing a suture line havinga predetermined dimension. When attached to the holder assembly, theflexible suture guide assumes a shape or geometry, such as acircumference, that conforms to the shape or geometry of that portion ofthe body organ or vessel that is being sutured. The holder assembly canbe formed to hold the suture guide in any desired shape, whetherstraight, curvilinear, or a combination of the two and the suture guidecan be either biodegradable or permanently implantable. Thus the surgeonundertaking reconstructive surgery is aided in achieving a suture lineof any desired shape, geometry and/or dimension.

[0038] The assembly includes a holder portion having a surface againstwhich the suture guide is positioned and held tautly in a fixed shape,geometry and/or dimension. More particularly, the holder assemblyincludes a body having an outwardly facing surface, generally flat,against which the suture guide is tautly positioned so that the sutureguide assumes the shape, geometry and/or dimension desired for thesuture line. Preferably, this surface is formed with at least onedepression for receiving a portion of the suture guide. The assemblyfurther includes a detachable handle and a mechanism for releasablybinding the suture guide to the surface.

[0039] The flexible suture guide used with the assembly of the inventioncomprises a generally elongated flexible body element having an internalflexible rib encased within a biocompatible covering, such as a wovencloth material. The suture guide can be formed of either biodegradableor non-biodegradable materials depending upon whether its purpose is toserve as a permanent support to prevent tearing out of the suturesplaced through it or whether the suture-supporting function is to be atemporary one. In addition to its function as a post-surgical supportfor sutures, during surgery when used in combination with the holderdisclosed herein, the suture guide serves as a rigid support andtemplate by which the surgeon controls the length of the finished sutureline. For instance, if the task is to suture together two ends of abowel from which a section has been removed, the combination of sutureguide and holder assure that the circumference of the surgical jointureis substantially similar to the circumference of the nearby regions ofthe colon, rather than smaller or larger.

[0040] Therefore, the holder device is designed to lend a temporaryrigidity or tautness to the suture guide while lending to it a shapeselected to facilitate the suturing task. For instance, when the task isto place a line of sutures around the circumference of a curvilinearsurface, the holder is designed to fit around at least a portion of thecircumference while holding the suture guide against the saidcircumference to aid the surgeon in making a surgical jointure that doesnot distort the said circumference.

[0041] In use, the suture guide is releasably retained against theoutwardly facing body surface by a means for releasable attachment, forexample one or more threads, pieces of Velcro™, and the like, placed sothat the suture guide lies along and temporarily substantially assumesthe shape of the body. The means for attachment may also be abiodegradable adhesive having the capacity to firmly attach the sutureguide to the holder body for sufficient time to complete the surgery,but having the capacity to dissolve or be dissolved once the suture linehas been placed. In one embodiment, the thread attaches the suture guideto the body surface at least at two points, for example at its extremeends, by passing at least partially through the suture guide and aboutthe body, i.e., by means of an in and out stitch or stitches.

[0042] The means for releasable attachment of the suture guide to thebody must be such that the suture guide can be released from the bodyonce the suture line has been placed by the surgeon without disturbingthe sutures sufficiently to cause dislocation or tearing of the suturesthrough the tissue. For example, if the means for releasable attachmentis one or more threads, a portion of the thread(s) affixing the sutureguide to the body can be positioned to be cut by scissors, or the like,to freely release the suture guide from the body. When the thread orthreads are cut or otherwise ruptured, the suture guide is freelyreleased from the body.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] The present invention is directed to a holder assembly forholding a substantially flexible, implantable suture guide in asubstantially taut position for suturing along a suture line having adesired shape or dimension, such as the desired circumference to whichan enlarged heart valve annulus is to be reduced by the formation ofpleats about the base of the valve annulus. The suture guide of theinvention is formed from a freely flexible rib encased within a wovencloth covering. In use, the flexible suture guide of the invention isheld taut by the holder assembly and in a configuration determined bythe shape of the holder assembly while the surgeon uses the supportprovided by the taut suture guide to evenly place the sutures and todraw the tissue by means of the sutures passed through the suture guideinto a suture line having a shape substantially similar to that of thesuture guide and holder. For example, for use in annuloplasty, theholder assembly can be C-shaped so that the suture guide temporarilyaffixed thereto assumes a C-shaped configuration. The suture guide canthen be sutured to the base of a heart valve annulus so as to restrictthe circumference of a dilated and/or deformed valve annulus to a morenormal one. When the suture guide is released from the holder, it willassume any shape that that portion of the body organ or vessel assumesin accordance with the dynamic function of the organ or vessel.

[0044] Generally the guide mount assembly includes a guide supportformed with a shape similar to that of the desired suture line, as inthe above example wherein the holder assembly is in the general shape ofthe valve annulus about which the suture guide is to be surgicallyplaced to assist in holding pleats in the walls of the annulus. Thesuture guide is mounted along at least a portion of this guide support,for example along a straight or a curved portion.

[0045] The holder assembly allows the surgeon to properly position thesuture guide while the suture guide is used to draw the sutures andassociated tissue into the desired configuration during the suturingprocess. The freely flexible suture guide is given temporary rigidityduring surgery by the detachable holder assembly, thus lending precisionto the surgeon in controlling the placement and location of the stitchesin the suture line. In an annuloplasty, for example, the potential forforming multiple plications as the circumference of the valve annulus isadjusted is thus greatly reduced.

[0046] Referring now to FIG. 1A, the suture guide 10 is an elongate,flexible member of a predetermined dimension. Due to its flexibility,the length of suture guide 10 can be manipulated to assume any desiredshape, ie., circular, C-shaped, straight, curvilinear or a combinationof curvilinear and straight segments. In FIG. 1B, suture guide 10 isshown as shaped into a ring by suturing the two ends together withsutures 11. As shown in FIG. 1A, suture guide 10 comprises asubstantially flexible inner rib 14 encased within covering 16.

[0047] Rib 14 comprises a flat, rod-like or tubular piece ofbiocompatible resilient, flexible material, such as mylar or siliconerubber. Rib 14 can also contain a substance opaque to x-rays, forexample, about 10 to 15 weight percent, preferably 13 weight percent, ofbarium sulfate so that the location of the suture guide can bedetermined in post-operative x-rays. The outer covering 16 is formedfrom any biocompatible material having sufficient strength to serve asan anchor to sutures without tearing and sufficient flexibility to beformed into a tight covering for rib 14 without restricting flexibilityof suture guide 10. Preferably, the outer covering 16 is a woven clothhaving a nap to encourage tissue ingrowth, for example a dacron velour.This outer covering 16 is tightly wrapped and sewn about frame 14 so asto completely encase it. The thickness of the outer cloth 16 issufficient to allow the surgeon to pass a suture therethrough.

[0048]FIG. 1 shows an exploded view of one embodiment of a holderassembly to which a suture guide is mounted, as seen generally at 12 and10 respectively. The holder assembly 12 includes a guide mount assembly18 and handle assembly 40 comprising a handle 42 and housing 44.

[0049]FIGS. 2 through 5 illustrate in greater detail the guide mountassembly 18 and how the suture guide 10 is mounted thereon. Guide mountassembly 18 includes a guide support 20. For illustrative purposes, thesuture guide assembly 18 here shown is one intended for use in plicationof a distended heart valve annulus. Therefore facing edge of guidesupport 20 is generally C-shaped or annular, having a shape andcircumferential dimension similar to that the surgeon desires to achievein the human heart annulus by means of annuloplasty surgery. Moreparticularly, support 20 is generally lenticular, having a C-shapedportion 28, with its ends connected by a straight side 30.

[0050] The suture guide 10 is fitted into a groove or trough 32 locatedabout the curved C-shaped portion 28 of the guide support 20 Trough 32is dimensioned to receive a portion of the suture guide 10, as best seenin FIG. 4. The positioning of the suture guide 10 within the trough 32conforms guide 10 to the shape of the guide support 20 while exposing asubstantial portion of the covering 16 outside of the trough 32 to allowthe surgeon to pass a suture therethrough.

[0051] In the embodiment shown in FIGS. 2-5, the guide mount assembly 18also includes a central support hub 22 to which the guide support 20 isattached by a multiplicity of integrally formed spokes, preferablythree, one of which is seen at 24. The arrangement of mount assembly 18including, in this instance, a curved guide support 20 with hub 22 andspokes 24, allows the surgeon to visually observe the heart valve duringthe suturing process. Central support hub 22 is formed with an annulargroove 36. This groove 36 is formed proximate that end 34 of hub 22opposite guide support 20, and defines a post member 38. That portion ofhub 22 remaining on the side of the groove 36 opposite the guide support20, and hub end 34, includes an inwardly tapering peripheral surface, asseen generally at 35. The hub 22 also includes an open bore 37 throughwhich is fitted a cylindrical plug 39. The plug 39 is dimensioned toextend out from both sides of the bore 37. The purpose of taperedsurface 35, and the plug 39 will be described hereinafter.

[0052] As is further seen in FIG. 1, the handle assembly 40 includes anelongated handle 42 having end 54 mounted to housing 44. While housing44 may be integrally formed at the end 54 of the post 42, preferably end54 is formed with outwardly facing threads that threadably mate withthreads formed along a surface of an opening 59 formed in the top of thehousing 44. The opposite end of post 42 is formed with an externaletched surface 52 to assist the surgeon in gripping post 42. In anotherembodiment, end 54 of post 42 and opening 59 of housing 44 can be formedso that end 54 can be press fit into opening 59.

[0053] Housing 44 is a thimble-shaped structure having a circular wall60 defining a cavity 46. As seen better in FIG. 4, cavity 46 is open atone side, seen generally as opening 45. The inner surface of thecircular wall 60 inwardly converges a short distance from the opening45. The cavity 46 is generally wide enough at the open side 45 to snuglyreceive hub 22, but the plug 39 extends sufficiently outward from hub 22to prevent passage through open side 45 into cavity 46. Wall 60 isformed with two J-shaped notches, seen at 48 and 49 in FIGS. 2 and 3.These J-shaped notches 48 and 49 are formed and positioned torespectively receive the ends of the plug 39 extending outward from thehub 22. The shape of the notches 48 and 49 defines a landing 50 betweenthe long and short legs of each notch.

[0054] Handle assembly 40 is coupled to the guide mount assembly 18 byinserting end 34 of the hub 22 into the cavity 46, with one of theoutwardly extending ends of the plug 39 passing through a respective oneof the J-shaped notches 48 and 49. The tapered surface 35 of the hub 22engages the inwardly tapering surface of the wall 60. This causes aslight compression of the hub end 34, resulting in a spring force. Thespring force acts to restrain the movement of the outwardly extendingends of the plug 39 through the larger legs of the J-shaped notches 48and 49. Additional exertion moves the ends of plug 39 through the largerlegs of J-shaped notches 48 and 49, with rotation of handle 40 passingthe outward ends of plug 39 across the landings 50 and into the smallerleg of the J-shaped notches 48 and 49.

[0055] The spring force established by the slight compression of the hubend 34 maintains the coupling between housing 44 and guide mountassembly 18. The handle 40 is decoupled from the guide mount assembly 18by reversing the described procedure.

[0056] One embodiment of the means for releasably attaching suture guide10 to guide support 20 of guide mount assembly 18 is seen in FIG. 5.Guide support 20 is formed with two apertures 66 and 68 extendingthrough guide support 20 and communicating with groove 32. The exactpositioning of apertures 66 and 68 is not critical. As illustrated,apertures 66 and 68 are formed along the straight portion of guidesupport 20, at a location proximate two of the spokes 24.

[0057] One end 71 of a cord or suture thread 70 is passed through one ofthe apertures, as illustrated hole 66, and tied off on guide support 20.The other end 73 of suture 70 is passed through the body of suture guide10 from one end to the other. This end 73 is then passed first throughhole 68 and then through and tied off at hole 66. After suture guide 10is sutured into position during surgery, ire., about the valve annulus,that portion of the suture 70 between apertures 66 and 68 is snipped orcut in two. Suture 70 passes-out of suture guide 10 by withdrawing thehandle assembly 12.

[0058] In accordance with another embodiment (not shown), the first end71 is tied off at hole 66, with the second end 73 passed first throughone end of the suture guide 10, and then brought back across and passedthrough the other end of suture guide 10, through hole 68 and again tiedoff at hole 66. Removal of suture 70 is accomplished by snipping thesuture in two at any point between the two holes and withdrawing it.

[0059] An alternative embodiment of the guide mount assembly so as seenin FIG. 6 includes a guide support 82 having an open C-shaped side 84but no straight side joining the ends of the C. Except for the stateddifference in shape of the guide support 82, guide mount assembly 80 inFIG. 6 includes elements similar to those described for the suture guideof FIG. 5 (as is indicated by the prime of the previously providedelement number), and will be described in no further detail herein. Inthis embodiment of guide mount assembly 80, the means for releasablyattaching the suture guide to the guide support is a suture (not shown)positioned by tying off as described above across an open space betweenholes 68′ and 66′ (not shown).

[0060] In a preferred embodiment of the invention, the handle assembly40 is tethered to the guide mount assembly 18. As seen in FIG. 1, thistethering is performed by connecting one end of a lanyard, seengenerally at 100, to the handle assembly 40 and the other end of thelanyard 100 to the guide support 20, for instance to one of spokes 24.Lanyard 100 allows a surgeon to detach the handle assembly 40 from theguide support 20 during the suturing procedure to get a clearer view ofthe surgical site. By tethering handle 40 to the guide mount assembly18, the risk of the surgeon leaving the guide support 20 in the patientafter completion of the surgical procedure is greatly reduced. Lanyard100 also allows the surgeon to easily remove the guide support 20 afterthe handle has been detached.

[0061] In a still further preferred embodiment, a handle assembly 40 ismodified to house a spool of suture or string that acts like a tetherfor the guide mount assembly. The tether is attached at opposite ends tothe handle assembly and the guide mount assembly respectively andautomatically spools out of the handle assembly when the handle isdisconnected from the guide mount assembly.

[0062] This preferred embodiment is better seen in the several FIGS. 8through 10. The lower portion of a handle assembly in accordance withthis embodiment is seen in FIG. 8 at 90. Handle assembly 90 includes ahousing 92, a handle extension 94, and a handle post 96.

[0063] Housing 92 includes a pair of opposing J-shaped notches 98 and 99that function similarly to the J-shaped notches 48 and 49 describedabove. The handle extension 94 is fastened to the lower end of thehandle post 96 in any suitable manner. As shown, the handle extension 94includes at one end a bore 102 for receiving the lower end 104 of thehandle post 96. End 104 of the handle post may be held in bore 102 bywelding, stamping, or by providing the respective members withinterlocking threaded surfaces. Accordingly, neither of these structuresof the handle assembly 90 will be discussed in any greater detail.

[0064] The main distinction to the previously described embodiment isthat the handle assembly 90 is formed to carry a spool of suture, seengenerally at 106. This suture spool 106 is housed in a bore 112 formedin the handle extension 94. Handle extension 94 and housing 92 areformed to releasably fit together. Handle extension 94 and housing 92include mating collars 108 and 110, respectively. Collar 108 is formedwith a groove 114 that receives a tongue 116 extending upward fromcollar 110. Tongue 116 is formed with a central aperture 122, and twoopposing cut-aways 118 and 120 that extend out in opposite directionsfrom this aperture 122.

[0065] Each of the collars 108 and 110 possesses four apertures.Apertures 126-129 of collar 108 align with apertures 130-133 of collar110 when the handle extension 94 and housing 92 are fitted together.

[0066] Suture spool 106 comprises a length of suture wound into acylindrical configuration along lower end 104 of handle post 96, whichfits into bore 112. The opposite ends of this suture length are tied tothe tongue 116 and the handle extension 94. One end of the suture isdrawn through the central aperture of 122 and tied to tongue 116, asseen at 115. The opposite end of the suture is drawn through an opening124 extending from the bore 112 through the handle extension 94 and istied around the handle extension 94, as seen at 117. It should be notedthat for the purpose of this invention, the meaning of the term “suture”shall include any cord, string or filamentous material useful fortethering the housing 92 to the handle extension 94.

[0067] Handle extension 94 and housing 92 are fitted together by placingthe tongue 116 into the groove 114. Sutures are run through alignedapertures to hold the handle extension 94 and housing 92 together. Forexample, one suture 134 is passed through apertures 126 and 127 ofhandle extension 94 and apertures 130 and 131 of housing 92, while asecond suture 136 is passed through apertures 128 and 129 of handleextension 94 and apertures 132 and 133 of housing 92.

[0068] The handle assembly 90 of this embodiment is coupled to the guidemount assembly 18 as stated above. The handle post 96 is removed fromthe housing 92 by cutting the sutures 134 and 136 and pulling the handleextension 94 away from the housing 92. Pulling away the handle post 96unravels the suture spool 106. After the suture guide is-sutured intoposition along the suture line, i.e., about a heart valve annulus, thesuture(s) holding the guide mount assembly to the suture guide is cut.The guide mount assembly is then removed by pulling on the handle post96.

[0069] In another embodiment of the invention, shown in FIGS. 11-13,handle assembly 140 is also modified to house a spool of suture orstring that acts like a tether for the guide mount assembly 142.Referring to FIG. 11, handle assembly 140, includes housing 144, handlepost 146, and an enlarged handle portion 148. Handle post 146 ispreferably made of a malleable metal or other material that allows thesurgeon to bend the handle to the desired angle while using the sutureguide holder assembly. The enlarged handle portion 148 allows thesurgeon to grip the handle more easily and also makes it easier for thesurgeon to maneuver the suture guide holder into the surgery site.Housing 144 is releasably attached to guide mount 150 as will bedescribed in more detail with reference to FIG. 12. Suture guide 152 isreleasably attached to guide mount 150 by threads or sutures (not shown)in a manner which will be described with reference to FIG. 13.

[0070] Referring to FIG. 12, housing 144 includes bore 154 for receivinghandle post 146. The end of handle post 146 may be held in bore 154 by apress fit or friction fit, by welding, or by providing the respectivemembers with interlocking threaded surfaces. Housing 144 also includes apair of opposing slots 156 for receiving dog ears 158 of the suturespool 160. Suture spool 160 includes a length of suture or thread 162wound into a cylindrical configuration along spindle post 164. One endof the suture 162 is tied to an aperture (not shown) in upper end 166 ofsuture spool 160. The other end of suture 162 is affixed to hub 168 ofguide mount 150. Specifically, suture 162 passes down through aperture170, up through aperture 172, and is tied off at aperture 112. The lowerend of spindle post 164 has a pair of opposing notches 174 formedtherein which are sized to be received by bore 176 of hub 168. Spindlepost 164, therefore, is press fit or friction fit into bore 176.

[0071] Suture spool 160 is housed within the interior cavity (not shown)of housing 144 and is held in place when dog ears 158 snap fit intoopposing slots 156. Housing 144 with suture spool 160 in place is thenreleasably attached to guide mount 150 by sutures or threads 178 and 180shown in FIG. 11. Suture 180 passes through a pair of apertures 182 inhousing 144 and a pair of apertures 184 in guide mount 150 asillustrated by dotted lines 186 in FIG. 12. Suture 178 passes through apair of apertures 188 in housing 144 and a pair of apertures 190 inguide mount 150 as shown by dotted lines 192 in FIG. 12.

[0072] Once the suture guide and guide mount assembly has been placed atthe surgery site, the surgeon can remove the handle if desired bycutting sutures or threads 178 and 180 at the location of the cuttingguides 194 and 196 shown in FIGS. 11 and 12. Cutting guides 194 and 196consist of a raised platform with a shallow groove 195 formed thereinthrough which the suture passes and a deeper groove 197 formed in theplatform perpendicular to the shallow groove through which scissors orother cutting tools can be inserted to clip or cut the suture at thatlocation. When the sutures are cut and the handle is removed, spool 160remains within housing 144 and suture 162 remains attached to hub 168.As the handle is pulled away from the guide mount, the suture or threadspools off spindle post 164 thereby providing a tether for removal ofthe guide mount after the suture guide has been detached from the guidemount and the surgery has been completed.

[0073] Referring to FIG. 13, suture guide 152 is releasably attached toguide mount 150 by sutures or threads 198, 200 and 202. Suture 198 istied off at aperture 204 and then passes through one end of the sutureguide and up through aperture 206 over cutting guide 208 down throughaperture 206 again, through suture guide 152, through aperture 209, thenup through aperture 210 where the other end of suture 198 is tied off.Suture 200 is at one end tied off through aperture 210 and then passesunder the guide mount 150 through aperture 211, through suture guide 152and up through aperture 212, across cutting guide 214 and back downthrough aperture 212. Suture 200 then passes through suture guide 152again, through aperture 215 and up through aperture 216 where it is tiedoff. Finally, suture 202 is tied off at one end at aperture 216 andpasses under suture guide 150 through aperture 217, through suture guide152, up through aperture 218, across cutting guide 220, down throughaperture 218 again where it passes through suture guide 152 and upthrough aperture 222 where it is tied off.

[0074] Apertures 224 and 226 disposed in guide mount 150 at oppositeends of the suture guide 152 are used to temporarily attach each end ofsuture guide 152 to each end of the guide mount 150 to hold the sutureguide in place during the process of threading sutures 198, 200 and 202through the apertures of the guide mount and the suture guide. Once thethreading of sutures 198, 200 and 202 is complete, the sutures at 224and 226 are then removed. The sutures at 224 and 226 are shown forillustration purposes in FIG. 11 at 223 and 225.

[0075] Referring to FIG. 13, cutting guides 208, 214 and 220 consist ofa raised platform with a shallow groove 228 formed therein through whichthe suture passes and a deeper groove 230 formed in the platformperpendicular to the shallow groove through which a cutting tool maypass in order to cut the suture at the location lying over the deepergroove. The deeper groove is closed at one end by a stop 232 so that thetip of the cutting tool or scissors cannot pass beyond that point. Thisstop prevents the cutting tool from dipping down into the open space 234between the spokes of guide mount 150 and accidentally cutting thetissue of the patient.

[0076] When the surgeon is ready to release the suture guide from thesuture guide mount 150 he merely snips the sutures 198, 200 and 202 bypassing the cutting tool into the cutting groove of the cutting guides.When the sutures have been snipped at all three locations, the guidemount can be retrieved by pulling on the tether or otherwise removing itand sutures 198, 200 and 202 are removed with the guide mount 150 sincethey are tied off on the guide mount.

[0077] Referring to FIGS. 14 through 18, there are shown two additionalembodiments of suture guide holders for holding a suture guide. FIGS. 14and 15 illustrate a linear suture guide holder for placing a linearsuture guide. FIGS. 16, 17 and 18 illustrate a circular or ring-shapedsuture guide holder for placing a circular suture guide.

[0078] Referring to FIG. 14, the linear suture guide holder has adetachable handle 240 of the type shown in FIG. 2 and linear-shapedguide mount 242. However, the handle embodiment with the tetherillustrated in FIGS. 8 and 12 could also be used. Guide mount 242 has alinear groove or trough 244 into which suture guide 246 is fitted asshown in FIG. 15. Apertures 248 formed in guide mount 242 are used tosuture the suture guide to the guide mount as shown in FIG. 15. Guidemount 242 also includes cutting guides 252 and 254 at each end of theguide mount.

[0079] Suture guide 246 is tautly secured to the linear guide mount 242by suture 250. One end of suture 250 is tied off at aperture 248 a,passes through suture guide 246 up through aperture 248 b cross cuttingguide 252 down through aperture 248 c through suture guide 246 upthrough aperture 248 d where it is tied to a second length of suture256. Suture 256 is threaded down through aperture 248 e through sutureguide 246 up through aperture 248 f across cutting guide 254 downthrough aperture 248 g through suture guide 246 and up through aperture248 h where it is tied off. Thus, as in previous embodiments, when thesurgeon is ready to release the suture guide from the suture guideholder, he merely inserts the cutting tool in the cutting grooves 252and 254 and cuts sutures 250 and 256 at that location. Suture 250 and256 are then removed with the suture guide mount 242. The linear sutureguide shown in FIGS. 14 and 15 would be used for any surgical procedurein which the incision is a substantially straight line. The suture guidemount 242 can be any desired length and the suture guide 246 can extendthe full length of the suture guide mount 242 as shown in FIG. 15 orcould be of a shorter length and sutured to just a portion of sutureguide mount 242. If the surgeon desires a suture guide with a hook orcurved end, the suture guide could extend around the edge of sutureguide mount 242 to provide one or two curved or hooked ends.

[0080] Referring to FIG. 16, there is shown a circular suture guideholder which would be useful for suturing two blood vessels or othervessels, such as intestines, together. It would also be useful for boweland bronchial resection. The suture guide holder has a handle 260 whichin this embodiment is not shown to be detachable. However, any of thevarious handle embodiments illustrated previously could be utilized,including the tethering concepts. The suture guide mount 258 is ringshaped with a groove or trough 260 formed on the interior cylindricalsurface of the ring. The groove or trough 260 is shaped to receive acircular suture guide 261 as shown in FIG. 17. Suture guide mount 258has a plurality of apertures 262 evenly spaced about its circumferencefor use in suturing the suture guide 261 to the suture guide holder asshown in FIG. 17. Suture 264 is threaded through the apertures andthrough the suture ring in a manner similar to that described withreference to FIGS. 14 and 15 and will not be further be described inconnection with this embodiment. Suture 264 can be clipped at twolocations such as at 266 and 268 in order release the suture guide fromthe suture guide holder. Alternatively, cutting guides can be providedas shown in the embodiments previously described and illustrated.

[0081]FIG. 18 shows a cross section of the suture guide holder with thesuture guide attached thereto taken along line 18-18 of FIG. 17. FIG. 18illustrates how groove 260 engages suture guide 261 and depicts rib 263and the outer covering 265 of the suture guide.

[0082] Various shaped suture guide holders, C-shaped, linear andcircular, have been described and illustrated in the figures, however,in accordance with the present invention, the suture guide holder can beconstructed in any desired shape depending on the surgical procedureinvolved. For example, the suture guide holder could be curvilinear forstomach reduction surgery or for certain cosmetic surgeries when it isnecessary to place a suture line along an eyelid or an ear.

[0083] While the preferred embodiments have been described, variousmodifications and substitutions may be made thereto without departingfrom the scope of the invention. Accordingly, it is to be understoodthat the invention has been described by way of illustration and notlimitation.

What is claimed is:
 1. A combination comprising: a biocompatible freelyflexible surgical suture guide of predetermined length; a rigid holderfor holding the suture guide in a taut fashion along the said length;and releasable retaining means associated with said holder means forreleasably holding the freely flexible suture guide in the taut fashion;wherein, upon release of the suture guide from the holder by thereleasable retaining means, the suture guide resumes flexibility.
 2. Thecombination of claim 1 wherein the suture guide is fashioned frombiocompatible biodegradable materials.
 3. The combination of claim 1wherein the suture guide is fashioned from non-biodegradablebiocompatible materials suitable for permanent implant.
 4. Thecombination of claim 3 wherein the surface of the suture guideencourages tissue ingrowth.
 5. The combination of claim 2 wherein thesuture guide comprises a flexible internal rib encased within asuturable covering.
 6. The combination of claim 5 wherein the suturablecovering is dacron velour.
 7. The combination of claim 1 wherein theholder includes: guide mounting means defining a surface against whichthe suture guide is tautly positioned by the releasable retaining means;and a handle coupled to the mounting means and formed to be grippedduring the placement of sutures through the suture guide.
 8. Thecombination of claim 7 wherein the guide mounting means has a shapeselected to hold the length of suture guide in a predeterminedconfiguration.
 9. The combination of claim 8 wherein the configurationis a predetermined circumference.
 10. The combination of claim 8 whereinthe configuration is at least a portion of a predeterminedcircumference.
 11. The combination of claim 8 wherein the configurationis substantially linear and has a predetermined dimension.
 12. Thecombination of claim 8 wherein the configuration is curvilinear and hasa predetermined dimension.
 13. The combination of claim 2 wherein thehandle is releasably connected to the guide mounting means.
 14. Thecombination of claim 7 wherein the surface defined by the mounting meanscomprises an outwardly facing channel into which the suture guide is atleast partially fitted.
 15. The combination of claim 1 wherein thereleasable retaining means comprises a tethering means for extendiblyattaching the handle to the mounting means.
 16. The suture guide andholder assembly of claim 15 wherein the tethering means comprises alanyard having first and second ends, with one of the ends beingconnected to the handle and the other end being connected to themounting means.
 17. The suture guide and holder of claim 1 wherein thereleasable retaining means comprises at least a first thread having twoopposing ends, each selectively affixed to the mounting means, with aportion of the thread being passed through a portion of the sutureguide.
 18. The suture guide and holder assembly of claim 15 wherein thereleasable retaining means comprises at least a first thread having twoopposing ends, each selectively affixed to the mounting means, with aportion of the thread being passed through a portion of the sutureguide.
 19. The suture guide and holder assembly of claim 16 wherein saidreleasable retaining means comprises at least a first thread having twoopposing ends, each selectively affixed to the mounting means, with aportion of the thread being passed through a portion of the sutureguide.
 20. A suture guide and holder assembly comprising: asubstantially flexible suture guide of predetermined length having asuturable covering; a rigid body defining a shaped surface against whichthe suture guide is releasably positioned along said predeterminedlength; releasable retaining means for tautly and releasably retainingthe suture guide against the shaped surface; a handle detachably coupledto the body; and means for tethering the handle to the body.
 21. Theassembly of claim 20 wherein the suture guide is a substantiallyelongated, straight flexible member comprising a substantially flexibleinner rib and a woven cloth covering encasing the rib.
 22. The assemblyof claim 20 wherein the tethering means comprises: a spool of a lengthof filamentous material secured at one end to the body and at anopposite end to the handle wherein the spool is housed within a cavityin the body.
 23. The assembly of claim 20 wherein the tethering meanscomprises a length of filamentous material attached at one end to thebody and at an opposite end to the handle.
 24. The assembly of claim 20wherein the body is C-shaped.
 25. The assembly of claim 20 wherein theshape of the body is lenticular and wherein the suture guide ispositioned along the portion of the lenticular surface having thelargest radius of curvature.
 26. The assembly of claim 20 wherein theretaining means comprises at least one filamentous strand thatselectively stitches together respective ends of the suture guide and isattached to the body.
 27. The assembly of claim 20 wherein the bodycomprises a holder formed with an outwardly facing surface against whichthe suture guide is positioned, said surface including one or moredepressions for receiving a portion of the suture guide, and wherein thereleasable retaining means includes at least a first thread affixed atboth ends to the holder with a first portion passing at least partiallythrough the suture guide, with the thread ends being affixed to theholder to expose at least one further portion of the thread that, whendissected, allows the suture guide to be freely released from theholder, and wherein the suture guide resumes free flexibility uponrelease from the holder.
 28. The assembly of claim 22 wherein the holdercomprising C-shaped body formed with an outwardly facing surface againstwhich the suture guide is releasably affixed by the retaining means,said surface including one or more depressions for receiving a portionof the suture guide, and wherein the releasable retaining means includesat least a first thread affixed at both ends to the holder with a firstportion passing at least partially through the suture guide, with theends of the thread being affixed to the holder to expose a secondportion of said thread that, when cut in two, subdivides said threadinto two pieces, each affixed at one end to the holder, with at leastone of the pieces defining the first portion being freely withdrawablefrom the suture guide to release the suture guide from the holder. 29.The suture guide and holder assembly of claim 20 wherein said sutureguide comprises a flexible rib encased within a woven fabric covering.30. The suture guide and holder assembly of claim 9 wherein said sutureguide comprises a flexible rib encased within a Dacron velour fabriccovering.